- JN -022023-1924665
- Jan 27, 2023
An excellent opportunity has arisen for a Senior Manager in device development assurance to join a speciality company based in Dublin.
This role will be a permanent position and it is an exciting time to join the company as they have several new and existing projects ongoing.
The successful candidate will have minimum 8 years' experience working in a similar role in device development and manufacturing operations in a GMP environment. 3 of those years will be managing teams providing technical direction. You will have experience in Medical Device, Pharma with device or combination device. A solid understanding of ISO13485 and GMP is essential. Experience in design control and design assurance preferential. A degree in Biomedical, Mechanical or Science essential.
- Lead a team of Device Development Engineers to ensure design assurance principles are effectively and consistently applied across the site and the Combination Product/Medical Device Development program teams.
- Drive continuous improvement projects and initiatives across the site.
- Support device development programs through the design and development lifecycle for Combination products and medical devices by compliance to design control requirements.
- Ensure Design History Files are established and maintained for development programs.
- Liaise with Affiliate sites and Third Parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
- Support the integration, and assess compliance with design assurance requirements, of acquired combination products and medical devices, into the product portfolio.
- Support Risk Management activities through the entire life cycle of medical devices and combination products through the implementation of ISO 14971:2019.
- Support maintenance of ISO 13485:2016 Quality Management System certification through involvement in Internal Audits, CAPA, Complaints, while ensuring relevant Regulatory requirements are adhered to.
- Participate in external audits.
- Establish best practice training to internal and affiliate personnel, to ensure compliance with local requirements and global policies.
- Maintain awareness of ongoing industry best practices, new QSRs and QMS requirements as they are developed, and implement improvement actions for the QMS.
If this role is of interest please 'apply now' or contact me on 021 2300 300 or at
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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